Registration Dossier

Administrative data

Endpoint:
carcinogenicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1959
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Sufficient data to be taken into account. Purity not indiacted.

Data source

Reference
Reference Type:
publication
Title:
The tumor-promoting action of phenol and related compounds for mouse skin.
Author:
Boutwell RK, Bosch DK
Year:
1959
Bibliographic source:
Cancer Res. 19, 413-427

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method: i tumour promotion test
Initiator: single dermal appl. of 0.3 % 9,10-dimethyl-1,2-benzanthracene (DMBA) in acetone;
Promotor: o-cresol (in benzene) was applied dermally twice per week, 12 weeks
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
other: Sutter
Sex:
female

Administration / exposure

Route of administration:
dermal
Vehicle:
other: DMBA in Acetone and the test substance in benzene
Details on exposure:
Initiator 0.3 % DMBA in acetone (benzene as control) Promotor: 20 % solution of the test substance.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
12 weeks
Frequency of treatment:
Initiator: once, promoter: twice a week
Post exposure period:
No
Doses / concentrations
Remarks:
Doses / Concentrations:
initiator: 75 ug DMBA in acetone, promoter: 250 mg/kg bw o-cresol in benzene
Basis:
nominal conc.
No. of animals per sex per dose:
27 test animals and 12 animals as control
Control animals:
yes

Examinations

Observations and examinations performed and frequency:
Once at termination : examination for skin tumour development

Results and discussion

Effect levels

Dose descriptor:
other: tumour promoting activity
Basis for effect level:
other: From tumour promotion studies in mice there are some indications that cresol may act as promotor

Any other information on results incl. tables

17/27 mice (12/12 benzene control animals) survived and in 59 % skin papillomas were found (0 % in control animals); no carcinomas were detected 22/27 mice treated with phenol survived; in 64 % skin papillomas were found; no carcinomas were detected.

Applicant's summary and conclusion